ISRCTN15412695已完成未知
A randomised controlled feasibility study to investigate the effects of a functional standing frame programme versus usual physiotherapy in people with severe sub-acute stroke on function, quality of life and neuromuscular impairment
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 45
研究概览
简要总结
2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29588861/ 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35241176/ (added 31/10/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. New (first/recurrent) clinical diagnosis of stroke, cerebral haemorrhage or infarct confirmed by consultant or CT scan leading to admission to the SRU
- •2. Aged 18 years and over
- •3. Graded as mRS 4 or 5 and/or NIHSS=16 (severe or very severe stroke and unable to stand without support/mechanical aid and assistance of two people)
- •4. Able to give informed consent or assent from a consultee
- •5. Conscious and responsive to verbal commands
排除标准
- •1. Systolic blood pressure =100mmHg or =220mmHg at rest lying or sitting
- •2. Oxygen saturation =87% with or without supplementary oxygen (e.g. severe acute/chronic cardiorespiratory disease)
- •3. Resting heart rate of =40 or =110 beats per minute (e.g. cardiovascular instability)
- •4. Temperature =38.5 degrees centigrade or =35 degrees centigrade
- •5. Orthopaedic impairments which prevent full weight bearing in standing
- •6. Malnutrition Universal Screening Tool score of =2, or not meeting nutritional demands for therapeutic interventions
- •7. Documented clinical decision for receiving end of life care
- •8. Unstable coronary or other medical condition that is judged by the PI/CI or clinical team to impose a medical risk to the patient by involvement in the study
- •9. Severe communication and/or cognitive deficit which affects their ability to follow instructions (e.g. assessed functionally by specialist clinicians as being a risk to themselves or others due to their inability to follow non-verbal prompts or are behaving erratically)
- •10. Immobile and not weight bearing pre-stroke
- •11. Additional neurological deficits unrelated to the current or past stroke (e.g. peripheral neuropathy or Multiple Sclerosis), because these impairments are not related to the condition of interest
- •12. Weight of 115kg or more, this is the weight limit on the standing frames
- •13. Being discharged out of county, e.g. admitted during holiday/visit to Cornwall or Devon because they would be unable to participate in follow-up assessments
- •14. Already registered in an intervention trial
研究者
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